Background
Method
Literature search
001 controlled clinical trials/ |
002 randomized controlled trials/ |
003 exp research design/ |
004 multi-center studies/ |
005 single-blind method/ |
006 clinical trial.pt. |
007 ((single or double or treble or triple) adj5 (mask$ or blind)).tw. |
008 placebos/or placebo$.tw. |
009 or/1–8 |
010 depress$.mp. [mp = title, original title, abstract, name of substance word, subject heading word] |
011 (family practi$ or general practi$ or primary care$ or family physician$).mp. [mp = title, original title, abstract, name of substance word, subject heading word] |
012 9 and 10 and 11 |
Data extraction
Results
First Author and Year | Study location, participant inclusion criteria, method of randomization and sample size. |
---|---|
Katon 1996 [16] | • Puget Sound, USA • Adults (18–80 yrs) considered by the GP as having "definite or probable major depression" were referred to the study over a one-year period and screened using the Symptom Checklist (SCL-20). Participants scoring >= .75 and who were willing to take anti-depressant medication were recruited into the study. Some exclusion criteria were applied. 74.1% were female. • Stratified (by SCL-20) with randomization of individual patients in blocks. • Usual Care (UC) n = 76 vs Collaborative Care Intervention (I) n = 77. |
Mann 1998. [17] | • UK-wide. • Adults (18–74 yrs) considered by the GP to have had depression for at least 4 weeks (regardless of prior treatment) were recruited into the study over a 2.5 year period (no further screening was undertaken). Some exclusion criteria were applied. 78% were female. • Simple randomization of individual patients. • Usual Care (UC) n = 148 vs Feedback & Nurse Monitoring Intervention (I) n = 271. • Note – Two interventions were conducted. Only the one meeting criteria for a system intervention is included here. |
Katon 1999. [18] | • Puget Sound, USA. • Adults (18–80 yrs) receiving a new anti-depressant prescription (i.e., no prescription in past 120 days) for anxiety or depression were identified by clinic databases. Screening was conducted 6–8 wks later to select for those with persistent symptoms of depression (as defined by Structured Clinical Interview for DSM-III-R (SCID) > 4 symptoms of depression, and Symptom Checklist (SCL-20) >1, or SCID<4 symptoms of depression but SCL-20>1.5). Some exclusion criteria were applied. 74.5% were female. • Stratified (by SCL-20) randomization of individual patients in blocks. • Usual Care (UC) n = 114 vs Stepped Collaborative Care Intervention (I) n = 114. |
Katzelnick 2000. [19] | • Wisonsin, Washington and Massachusetts, USA. • Adults (25–63 yrs) who were "high utilizers" of health clinic (ie, frequency of ambulatory visits above the 85th percentile) were identified on clinic databases. Eligible participants were screened for major depression or major depression in partial remission using the Structured Clinical Interview for DSM-IV (SCID). Patients meeting second-stage screening criteria on Hamilton Depression Rating Scale (Ham-D; scores = >15) were enrolled. Participants were not on anti-depressants at baseline. Some exclusion criteria were applied. 77% were female • Cluster randomization by practice. • Usual Care (UC) n = 189 vs Depression Management Program (I) n = 218. |
Simon 2000. [20] | • Puget Sound, USA • Adults (age range not reported) receiving a new prescription for anti-depressants (i.e., no prescription in past 120 days) were identified by clinic databases and recruited into the study. No further screening was undertaken. Some exclusion criteria were applied. Aprox. 72% were female. • Stratified (by clinic) with randomization of individual patients. • Usual Care (UC) n = 196 vs Feedback and Care Management Intervention (I) n = 196. • Note – Two interventions were conducted. Only the one meeting criteria for a system intervention and is included here. |
Wells 2000 [21,29,39] | • 7 regions in the USA. • Consecutive adults (18+yrs) attending clinics over a 5–7 month period were screened for probable or persistent depression using the Composite International Diagnostic Interview (CIDI – 2 weeks of depressed symptoms or probable depression in the past year, with at least one week of depression in the past month). Some exclusion criteria were applied. 71% were female. 30% of participants were Hispanic (deliberate choice of practices to oversample for Mexican Americans). • Cluster randomisation (by practice), matched in blocks of 3 on patient demographics, clinician specialty and distance to mental health providers. Stratification by proportion of Mexican American patients occurred in one region only. • Usual Care (UC) n = 443 vs Quality Improvement-Therapy (I-Therapy) n = 489 vs Quality Improvement-Medication (I-Meds) n = 424. |
Rost 2000 [22,27,30,40,41] | • Clinics across the USA. • Consecutive adults (18+yrs) attending clinics for routine-length visits were screened over an 18 month period for "probable major depression" on the WHO-Composite International Diagnostic Interview (CIDI – 2 weeks of depressed symptoms or probable depression in the past year, with at least one week of depression in the past month). Those meeting second-stage screening criteria on the Inventory to Diagnose Depression (IDD >5 of 9 depression symptoms in previous 2 weeks) were enrolled. Some exclusion criteria were applied. 84% were female. • Cluster randomization (by practice), matched in blocks (metro vs rural practices) on proportion of patients receiving guideline-concordant care. • Usual Care (UC) n = 240 vs Enhanced Care Intervention (I) n = 239 • Recovery was only reported for sub-groups of Rost's 2001 sample, in later publications. • Smith 02 – Exclusion of n = 96 elderly (65+) from Rost 2001 sample. 81% were female. Usual Care (UC) n = 195 (insured n = 150, uninsured n = 45) vs Enhanced Care Intervention (I) n = 188 (insured n = 140, uninsured n = 48). • Rost 2002 – Exclusion of n = 268 "treatment resistant" participants from Rost 2001 sample. 84% were female. Usual Care (UC) n = 96 vs Enhanced Care Intervention (I) n = 115 |
Datto 2003 [23] | • Pennsylvania, USA • Adults (age range not reported) with "symptoms suggestive of depression" were identified by the GP and recruited into the study (no further screening was undertaken). Some exclusion criteria were applied. 60.7% were female. • Cluster randomisation (by practice). • Usual Care (UC) n = 31 vs Telephone Disease Management Intervention (I) n = 30. |
Finley 2003 [26] | • California, USA. • Adults (age range not reported) were referred to the study by their primary care provider (GP) when starting new antidepressant medication (ie, no medication taken in past 6 months) for depression (no further screening was undertaken). Some exclusion criteria were applied. Patients were paid $20 at end of study. 85% were female • Simple randomization of individual patients. • Usual Care (UC) n = 50 vs Collaborative Care Intervention (I) n = 75. |
Capoccia 2004 [24,42], | • Seattle, USA (academic clinic) • Adults (18+) with a newly diagnosed depression episode and anti-depressant prescription (as determined by their health care provider) were referred to the study, then screened for depression using PRIME-MD (cut off criteria not reported). Some exclusion criteria were applied. 57% were female. • Simple randomization of individual patients. • Usual Care (UC) n = 33 vs Enhanced Care Intervention (I) n = 41 |
Dietrich 2004 [25] [43] | • Clinics across the USA • Adults 18+ who were commencing or changing treatment for depression were identified by clinicians and referred for a structured interview. Those with DSM-IV major depression or dysthymia, and with Hopkins Symptom Checklist-20 >= 0.5 were eligible. Participants had to be willing to take anti-depressant treatment or be referred for psychological counselling. Some exclusion criteria were applied. 80% were female. • Cluster randomization (by practice), stratified by health care organisation, and matched by GP specialty, presence of clinic mental health care and distance from the organisations central office. • Usual Care (n = 181) vs Quality Improvement Intervention (I) n = 224 |
Representativeness of sample and generalisability of results
Consort item # | Text in italics = consort criteria relevant to cluster randomised trials only. | Trials that reported information as outlined by CONSORTii Cluster RCTs are in bold. |
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1. Design | How participants were allocated to interventions (eg "random allocation", "randomised", or "randomly assigned"), specifying that allocation was based on clusters. | A, B, C, E, G, H, J, K, L
|
2. Background | Scientific background and explanation of rationale, including rationale for using a cluster design. | A, B, C, E, G, H, J, K |
3. Participants | Eligibility criteria for participants and clusters and the settings and locations where data were collected. | A, B, C, E, G, H, J, K, L
|
4. Interventions | Precise details of the interventions intended for each group, whether they pertain to the individual level, the cluster level, or both, and how and when they were actually administered. | A, B C, D, E, F, G, H, I, J, K, L
|
5. Objectives | Specific objectives and hypotheses and whether they pertain to the individual level, the cluster level, or both. | A, B C, D, E, F, G, H, I, J, K, L
|
6. Outcomes | Clearly defined primary and secondary outcome measures, and whether they pertain to the individual level, the cluster level, or both. | B, F, G, H, K, L
|
And, when applicable, any methods used to enhance the quality of measurements (eg, multiple observations, training of assessors) | Not assessed/judged | |
7a. Sample size | How total sample size was determined including method of calculation, number of clusters, cluster size, a coefficient of intracluster correlation (ICC or k), and an indication of its uncertainty). | B, E, J, K, L
|
7b. Sample size | And, when applicable, calculation of interim analyses and stopping rules. | K (no other article calculated interim analyses) |
8. Sequence generation | Method used to generate the random allocation sequence, including details of any restriction, (eg blocking, stratification, matching). | A, B, C, E, F, H, K, L
|
9. Allocation concealment | Method used to implement the random sequence (eg, numbered containers or central telephone), specifying that allocation was based on cluster rather than individuals and clarifying whether the sequence was concealed until interventions were assigned. | None |
10. Implementation | Who generated the allocation sequence, who enrolled participants and who assigned participants to their groups. |
G, H
|
11a. Blinding | Whether or not participants, those administering the interventions and those assessing the outcomes were blinded to group assignment. | J, K |
11b. Blinding | If done, how the success of blinding was evaluated. | F (no others assessed blinding)
|
12a. Statistical methods | Statistical methods used to compare groups for primary outcome(s), indicating how clustering was taken into account. |
A, B, C, D, E, F, G, H, J, K, L |
12b. Statistical methodsiii
| Methods for additional analyses, such as subgroup analyses and adjusted analyses |
F
|
13. Participant flowiv
| Flow of clusters and individual participants through each stage. Specifically for each group report the numbers of clusters and participants randomly assigned, receiving intended treatment, completing the study protocol and analysed for the primary outcome. | B, D, F, H (see footnote for further explanation) |
Describe protocol deviations from study as planned, together with reasons. | Not assessed/judged | |
14. Recruitment | Dates defining the periods of recruitment and follow-up | B, F, G, H, K, L
|
15. Baseline data | Baseline demographic and clinical characteristics for the individual and cluster levels as applicable. | A, B C, E, G, H, I, J, K, L
|
16. Numbers analysedv
| Number of clusters and participants (denominator) in each group included in [recovery] analyses and whether analysis [not specific to recovery] was by "intention to treat". State the results in absolute numbers when feasible (eg, 10/20 not 50%) | B, D, F, J, L
|
7. Outcomes and estimationv
| For [recovery analyses], a summary of results for each group for the individual or cluster level as applicable and the estimated effect size and its precision (eg, 95% CI)". |
None
|
18. Ancillary analyses | Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory. | None (N/A for L) |
19. Adverse events | All important adverse events or side effects in each intervention group. | None |
20. Interpretation | Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision and the dangers associated with multiplicity of analyses and outcomes. | None |
21. Generalisability | Generalisability (external validity) to individuals and/or clusters (as relevant) of the trial findings. | A, C, D, E, F, G, H, I, J, K, L
|
22. Overall evidence | General interpretation of results in the context of current evidence | A, B, D, E, F, G, H, I, J, K, L
|
1st Author and Date | Follow-up Times and Attrition | Measures of Recovery and Recovery Results |
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Katon 1996 & Lin 1999. | • F/U at 1, 4, 7 & 19 mths. • Attrition# at 4 mths: UC = 14/76* (18.4%*), I = 11/77* (14.3%*) • RA's completing F/U were blind to intervention status. | Recovery = Proportion with 1 or less symptoms of depression on the Inventory for Depressive Symptomatology (IDS). Recovery was only reported for sub-groups in the article (people with Major depression vs Minor depression). Usual Care and Intervention data were deduced from sub-group data provided. • At 4 mths: UC = 35/62* (56%*), I = 45/66* (68%*). No statistical comparisons were provided. |
Mann 1998. | • F/U at 4 mths. • Attrition: UC = 14/148 (9.5%), I = 20/271 (7.4%) • RA's completing F/U were not blind to intervention status. | Recovery = Change in proportion not meeting DSM-III criteria for major depression on the Nurse Assessment Interview (NAI) from baseline to follow-up. • At 4 mths: UC = 79/134* (59%*), I = 123/251* (49%*), ns. |
Katon 1999. | • F/U at 1, 3 & 6 mths. • Attrition at 3 mths: UC = 17/114* (14.9%*), I = 18/114* (15.8%*) • Attrition at 6 mths: UC = 17/114* (14.9%*), I = 19/114* (16.6%*) • RA's completing F/U were blind to intervention status. | Recovery = Proportion with 1 or 0 symptoms of depression on the Structured Clinical Interview (SCID) for DSM-IV. • At 3 months: UC = 22/97* (23%), I = 38/96* (40%), p = .01 • At 6 months: UC = 30/97* (31%), I = 42/95* (44%), p = .05 |
Katzelnick 2000. | • F/U at 6 wks, 3, 6 & 12 mths. • Attrition at 12 mths: UC = 12/189 (6.3%), I = 15/218 (6.9%). • RA's completing F/U were blind to intervention status. | Recovery = Proportion with Hamilton Depression Rating Scale (HDRS) < 7. • At 12 mths: UC = 49/177 (27.7%), I = 92/203 (45.3%), p < .001 • At 12 mths: Number to Treat = 5:1 |
Simon 2000. | • F/U at 3 & 6 mths. • Attrition not reported. • RA's completing F/U were blind to intervention status. | Recovery = The inverse of odds ratios for meeting criteria for major depression on the Structured Clinical Interview (SCID) for DSM-IV. • Across follow-ups, the Odds Ratio = 0.45 (0.24–0.86) indicates the probability of recovery was significantly higher in the Intervention group |
Wells 2000 & Sherbourne 2001 & Wells 2004. | • F/U at 6, 12, 24 & 57 mths. • Attrition at 6 mths: UC = 57/443 (12.9%), I = 143/913 (15.7%). • Attrition at 12 mths: UC = 69/443 (15.6%), I = 161/913 (17.6%). • Attrition at 24 mths (estim.): UC = 65/443* (14.7%), I-Meds = 62/424* (14.7%), I-Therapy = 72/489* (14.7%) • Attrition at 57 mths: UC = 131/443 (29.6%), I-Meds = 102/424 (24.0%), I-Therapy = 132/489 (27%) • RA's completing F/U were not blind to intervention status. | Recovery = Proportion no longer meeting probable or persistent depression on the Composite International Diagnostic Interview (CIDI). • At 6 mths, UC = 193/386* (50.1%*), I-Therapy & I-Meds combined = 463/770* (60.1%*), p = .005 • At 12 mths: UC = 183/374* (48.8*)%, I-Therapy & I-Meds combined = 439/752* (58.4%*), p = .04 • At 24 mths: UC = 223/338* (66%*) vs I-Meds = 221/362* (61%*), ns. UC = 223/338* (66%*) vs I-Therapy = 337/489* (69%*), ns • At 57 mths: UC = 176/312* (56.4%*) vs I-Meds = 200/322* (62.1%*), ns. UC = 176/312* (56.4%*) vs I-Therapy = 228/357* (63.8%*), p = .05 Recovery = Proportion with Center for Epidemiologic Studies – Depression (CES-D, Modified version) < 20. • At 6 mths: UC = 137/386* (35.6%), I-Therapy & I-Meds combined = 343/770* (44.6%*), p = .005 • At 12 mths: UC = 144/374* (38.6%), I-Therapy & I-Meds combined = 342/752* (45.5%*), p = .04 |
Rost 2001 & Smith 2002 & Rost 2002 | • F/U at 6, 12, 18 & 24 mths. • N = 479 were recruited to original trial (Rost 00). Smith 2002 and Rost 2002 are sub-group follow-ups. • Smith 02: Attrition at 24 mths: UC = 48/195* (24.6%*), I = 70/188 (36.7%*). • Rost 02: Attrition at 24 mths: UC = 13/96 (13.5%), I = 46/115 (40%) • RA's completing F/U were blind to intervention status. | Smith 2002 Recovery = Proportion not meeting Composite International Diagnostic Interview (CIDI) criteria for major depression. Recovery was only reported for sub-groups in this article (uninsured vs insured, no significant difference was found). Usual Care and Intervention data were deduced from sub-group data provided. • At 24 mths: UC = 113/148* (76.4%*), I = 92.5/119* (78%*). Rost 2002 Recovery = Proportion of participants with Centre for Epidemiological Studies-Depression (CES-D) <16. • At 24 mths: UC = 34/83* (41%) vs I = 51/69* (74%), p = .02 |
Datto 2003 | • F/U at 16 weeks. • Attrition at 16 weeks: UC = 5/31* (16.1%) vs I = 6/30* (20%) • Unclear if nurses completing F/U were blind to intervention status. | Recovery = Proportion of participants with Centre for Epidemiological Studies-Depression (CES-D) <11. • At 16 weeks: Odds Ratio = 3.48 (0.85–14.29), n.s (p = .08) Recovery = Proportion of participants with CES-D<16 • At 16 weeks: Odds ratios = 6.58 (1.57–27.03), significant (p = .01) in favour of intervention Recovery = Proportion of participants not meeting Mini-International Neuropsychiatric Interview (MINI) criteria for major depression. • At 16 weeks: Odds ratio = 0.52 (0.13–2.03), n.s, p = .66 |
Finley 2003 | • F/U at 6 mths • Attrition: UC = 25/50 (50%) vs I = 16/75 (21%) • F/U measures were completed by postal self-report questionnaires. | Recovery = Proportion of participants with Brief Inventory for Depressive Symptoms (BIDS) < 9 • At 6 mths UC = 14.6/25* (58.3%), I = 32.8/59* (55.6%), ns (p = .36) |
Capoccia 2004 | • F/U at 3, 6, 9 and 12 months. • Attrition by Total N: At 3 mths = 3/74 (4%), At 6 & 9 mths = 4/74 (5%), At 12 mths = 5/74 (7%) (attrition was approximately equal in both groups) • RA completing F/U was blind to intervention status. | Recovery = Proportion not meeting criteria for major depression on the Structured Clinical Interview (SCID) for DSM-IV and Symptom Checklist (SCL-20). Exact criteria/cut-offs were not specified. • % with major depression did not differ significantly @ 3, 6, 9, 12 mths, p = .32. • At 12 mths: Recovery deduced from data in article as: UC = 31/31* (100%*), I = 37/38* (97%*) |
Dietrich 2004 | • F/U at 3 & 6 months. • Attrition at 3 mths: UC = 29/181 (16%) vs I = 39/224 (17%) • Attrition at 6 mths: UC = 35/181 (19%) vs = 45/224 (20%) • Interviewers completing F/U were blind to intervention status. | Remission = Proportion with Symptom Checklist (SCL-20) < 0.5. • At 3 mths: UC = 25/152 (16.5%), I = 48/183 (26.2%), p = .018 • At 6 mths: UC = 39/146 (26.7%), I = 66/177 (37.3), p = .014 |